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Docetaxel and Ifosfamide in Treating Women With Metastatic Breast Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00026078
Recruitment Status : Unknown
Verified November 2006 by National Cancer Institute (NCI).
Recruitment status was:  Recruiting
First Posted : January 27, 2003
Last Update Posted : August 7, 2013
Information provided by:
National Cancer Institute (NCI)

Brief Summary:

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of docetaxel and ifosfamide in treating women who have metastatic breast cancer.

Condition or disease Intervention/treatment Phase
Breast Cancer Drug: docetaxel Drug: ifosfamide Phase 2

Detailed Description:


  • Determine the efficacy of docetaxel and ifosfamide as first-line chemotherapy in women with metastatic breast cancer.
  • Determine the response rate and duration of response of patients treated with this regimen.
  • Determine the time to treatment failure and survival of patients treated with this regimen.
  • Determine the toxicity of this regimen in these patients.
  • Determine the quality of life of patients treated with this regimen.

OUTLINE: This is a multicenter study.

Patients receive docetaxel IV over 1 hour on day 1 and ifosfamide IV over 1 hour (beginning 1 hour after docetaxel infusion) on days 1-3. Treatment continues every 4 weeks in the absence of disease progression or unacceptable toxicity.

Quality of life is assessed at baseline, every month during study, and then every 3 months after completion of study.

Patients are followed every 3 months.

PROJECTED ACCRUAL: A total of 15-42 patients will be accrued for this study.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 42 participants
Primary Purpose: Treatment
Official Title: Docetaxel (DTX) - Ifosfamide (IFX) As First Line Chemotherapy In Metastatic Breast Cancer
Study Start Date : March 2001

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Primary Outcome Measures :
  1. Response rate

Secondary Outcome Measures :
  1. Time to treatment failure
  2. Duration of response
  3. Survival
  4. Toxicity as assessed by CTC version 2.0
  5. Quality of life as assessed by Schipper's Functional Living Index - Cancer

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   21 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No


  • Histologically confirmed metastatic breast cancer
  • Bidimensionally measurable lesions

    • The following are not considered measurable:

      • Bone lesions
      • Leptomeningeal disease
      • Ascites
      • Pleural/pericardial effusion
      • Inflammatory breast disease
      • Lymphangitis cutis/pulmonis
  • Disease progression after hormonal therapy allowed provided at least 1 month since last therapeutic manipulation
  • No CNS metastases
  • Hormone receptor status:

    • Not specified



  • 21 to 75


  • Female

Menopausal status:

  • Not specified

Performance status:

  • ECOG 0-2 OR
  • Zubrod 0-2

Life expectancy:

  • More than 12 weeks


  • WBC at least 4,000/mm^3
  • Platelet count at least 100,000/mm^3
  • Hemoglobin at least 11 g/dL


  • Bilirubin no greater than 1.25 times upper limit of normal (ULN)
  • SGOT no greater than 1.25 times ULN


  • Creatinine clearance at least 60 mL/min


  • No history of congestive heart failure
  • No myocardial infarction within the past 6 months
  • No active ischemic heart disease
  • No uncontrolled hypertension


  • Not pregnant
  • No other prior or concurrent malignancy except properly treated basal cell skin cancer or carcinoma in situ of the cervix
  • No other medical or psychiatric diseases that would preclude study
  • No geographical situation that would preclude study
  • No history of alcohol abuse


Biologic therapy:

  • Not specified


  • No prior adjuvant chemotherapy including ifosfamide or docetaxel
  • No prior systemic chemotherapy for metastatic breast cancer

Endocrine therapy:

  • See Disease Characteristics
  • No concurrent corticoids, gestagens, or androgens unless strictly indicated


  • Not specified


  • Not specified


  • No concurrent drinks containing caffeine or alcohol

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00026078

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Grupo Oncologico Cooperativo del Sur Recruiting
Bahia Blanca, Buenos Aires, Argentina, 8000
Contact: Juan Eduardo Perez, MD    54-291-452-5667   
Policlinica Privada Instituto De Medicina Nuclear Recruiting
Bahia Blanca, Buenos Aires, Argentina, 8000
Contact: Alberto Omar Romero, MD    54-291-453-9848   
St. Joseph Medical Center Recruiting
Gonnet, Buenos Aires, Argentina, 1987 MB
Contact: Sergio Grasso, MD    54-221-4845088      
Sanatorio Santa Rosa S.R.L. Recruiting
Santa Rosa, La Pampa, Argentina, 6300
Contact: Eduardo Heriberto Ortiz, MD    54-2954-29-715      
C.R I O. Recruiting
Mar del Plata, Argentina, 7600
Contact: Ricardo L. Rodriguez, MD    54-223-479-3283   
Unidad Oncologica Del Neuquen Recruiting
Neuquen, Argentina
Contact: Bernardo A. Leone, MD    54-299-448-5247   
Centro Oncologico Tres Arroyos Recruiting
Tres Arroyos, Argentina, 7500
Contact: Maria Ester Dominguez, MD    0983-33450   
Centro Medico Nacional de Occidente Recruiting
Guadalajara, Jalisco, Mexico, 4430
Contact: Gilberto Morgan Villela, MD    523-641-5081      
Sponsors and Collaborators
Grupo Oncologico Cooperativo del Sur
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Study Chair: Bernardo A. Leone, MD Unidad Oncologica Del Neuquen

Layout table for additonal information Identifier: NCT00026078    
Other Study ID Numbers: GOCS-02-BR-01
CDR0000068969 ( Registry Identifier: PDQ (Physician Data Query) )
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: August 7, 2013
Last Verified: November 2006
Keywords provided by National Cancer Institute (NCI):
stage IV breast cancer
recurrent breast cancer
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Isophosphamide mustard
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Alkylating
Alkylating Agents